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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06960785




Registration number
NCT06960785
Ethics application status
Date submitted
29/04/2025
Date registered
7/05/2025
Date last updated
7/05/2025

Titles & IDs
Public title
Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
Scientific title
Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
Secondary ID [1] 0 0
GPAS-REF-024-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presbyopia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - MEL90 excimer laser - PRESBYOND

PRESBYOND - Participants in this group will receive a personalized laser eye surgery for the correction of presbyopia (Presbyond). The treatment is planned individually for each patient and performed on both eyes. It involves creating a corneal flap with a femtosecond laser, followed by reshaping the cornea with an excimer laser to improve vision at different distances. One eye is mainly corrected for distance and the other for near vision, allowing the brain to combine both images and support everyday visual tasks without glasses.


Treatment: Devices: MEL90 excimer laser - PRESBYOND
Participants will undergo laser eye surgery in both eyes using the PRESBYOND method. First, a thin flap is created on the surface of the eye using a femtosecond laser. Then, a second laser (excimer laser) reshapes the cornea to improve vision at near, intermediate, and far distances.

The treatment is similar to monovision techniques, where one eye is mainly corrected for distance and the other for near vision. However, PRESBYOND differs by adjusting the depth of focus in each eye individually, allowing the brain to better combine the two images in the intermediate range-this area is called the "Blend Zone." This approach helps preserve natural binocular (3D) vision, contrast sensitivity, and depth perception. Most patients adapt well and quickly to this type of correction. The procedure is customized based on each patient's age and eye characteristics.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better
Timepoint [1] 0 0
6 months after surgery

Eligibility
Key inclusion criteria
1. Subjects between 45 and 65 years old
2. Scheduled to undergo bilateral LASIK treatment with PRESBYOND
3. Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye
4. Normal corneal topography in each eye
5. Discontinue use of contact lenses at least 1 month for hard contacts and 1 week for soft lenses prior to the preoperative examination
6. Residual stromal thickness =250 microns in each eye
7. Availability, willingness, to comply with examination follow up visits
8. Signed informed consent and data protection documents
9. Patients successfully passed the tolerance test
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Mixed astigmatism in any eye
2. Irregular corneal astigmatism in any eye
3. Clinically significant ocular surface disease in any eye
4. History of ocular surgery, ocular pathology, or other significant ocular findings that, in the Investigator's opinion, may increase the patient's risk for corneal refractive surgery or affect potential visual outcomes in each eye
5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye
6. Amblyopia, strabismus, nystagmus, forme fruste keratoconus in any eye
7. Clinically significant pupil abnormalities in any eye
8. Use of systemic or ocular medications that may affect visual outcomes
9. Systemic pathology that may affect the results of the study
10. Pregnancy or being treated for conditions associated with hormonal fluctuation
11. Participation in another clinical trial in the last 30 days

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC/AustraliaWA
Recruitment hospital [1] 0 0
Eye Laser Specialists - Melbourne
Recruitment hospital [2] 0 0
Crystal Eye and laser Center - Craigie
Recruitment postcode(s) [1] 0 0
3143 - Melbourne
Recruitment postcode(s) [2] 0 0
6025 - Craigie
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Carl Zeiss Meditec AG
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GCP-Service International Ltd. & Co. KG
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06960785